DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicants' arguments, filed 08/10/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 6, 8, 12, 24, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Ogwapit (Bioscience Horizones, V4, N2, 2011, 128-139) as evidenced by Mizuno et al (J of Pharma Sci, 104:2482–2488, 2015).
Ogwapit discloses a tablet comprising
As active, Ge-132 at 5%, (Mizuno et al evidences that Ge-132 is another name for repagermanium (pg 2482, Introduction, second ¶).
MCC at 25-50% to improve compression and adhesive properties
HPMC at 4-10% as additional binder
tablet disintegrants (starch or crospovidone) at 10%,
Mg stearate at 1% to promote powder flow,
and lactose at 40-50% to increase bulk powder volume
(pg 130, right column, Preparation of uncoated Ge-132).
Ogwapit discloses ranges that overlap or are close (such as component iv). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05. Where the range is close, it would be obvious to vary the amount based on the disclosed purpose, i.e. reducing the amount of disintegrant to provide ideal tablet properties.
With regards to claim 12, where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. MPEP 2112.01(III). Here, the printed matter does not modify the kit, which comprises the tablet of claim 1.
Examiner notes that Applicants response 8/10/2026 included the assertion that Applicants found that the addition of 30 to 70% MCC, CSD, or SMCC overcomes problems of compounding the claimed actives. But Ogwaplit appears to disclose the fillers at the same concentration, and as such, it is unclear what the distinction is between Applicants claimed tablets and those of Ogwaplit. There are some ranges which overlap, and the disintegrant is slightly outside the instantly claimed range, but based on Applicants arguments, it is unclear if these are sufficient to render some unexpected result.
Claims 5, 7, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Ogwapit (Bioscience Horizones, V4, N2, 2011, 128-139) as evidenced by Mizuno et al (J of Pharma Sci, 104:2482–2488, 2015), in view of Soler (ES2622192).
Ogwapit is discussed above but does not teach silicified microcrystalline cellulose (SMCC) or sodium starch glycolate
Soler teaches common tablet diluents and fillers include MCC and SMCC (¶ 6). The disclosed disintegrants include sodium starch glycolate and starch (¶ 7).
It would have been obvious to substitute known excipients which are taught by the prior art to be functionally equivalent. MPEP 2144.06. Here, MCC and SMCC are equivalent fillers, and starch is an equivalent disintegrant of sodium starch glycolate.
Allowable Subject Matter
Claims 9, 14, 15, 19- 22, and 26-27 are allowed. The prior art does not teach the actives for the treatment of FSGS.
Conclusion
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 9/25/2026 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN J PACKARD whose telephone number is (571)270-3440. The examiner can normally be reached Mon 2-6pm and Tues-Fri 9:30am-6:30pm + mid-day flex.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup can be reached at (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BENJAMIN J PACKARD/ Primary Examiner, Art Unit 1612
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